Human challenge trials in vaccine development, Rockville, MD, USA, September 28–30, 2017. (September 2019)

• Record Type: Journal Article
• Authors: Baay, Marc F.D.; Richie, Thomas L.; Neels, Pieter
• Is Part Of: Biologicals. Volume 61(2019)
• Page Start: 85
• Page End: 94
• Publication Date: 2019-09
• Subjects: Human challenge -- Infection models -- Vaccine -- Efficacy -- Ethics; AMP auxiliary medicinal product -- BAL bronchoalveolar lavage -- CDER Center for Drug Evaluation and Research -- cGMP current Good Manufacturing Practices -- CHHI Controlled Human Hookworm Infection -- CHI controlled human infection -- CHMI controlled human malaria infection -- CIOMS Council for International Organization of Medical Sciences -- DCVRN Developing Country Vaccine Regulators' Network -- DENV Dengue virus -- EMA European Medicines Agency -- ETEC Enterotoxic Escherichia coli -- EU European Union -- FDA United States Food & Drug Administration -- GCP Good Clinical Practice -- HCT human challenge trial -- HMPV Human metapneumovirus -- IABS International Alliance for Biological Standardization -- IMP Investigational Medicinal Product -- IND Investigational New Drug -- RCT randomized controlled trial -- IRB institutional review board -- LAIV live attenuated influenza virus -- NAT nucleic acid testing -- PCR polymerase chain reaction -- PfSPZ Plasmodium falciparum sporozoites -- QC Quality Control -- RSV respiratory syncytial virus -- TBS thick blood smear -- TFDA Tanzanian Food and Drug Agency -- WHO World Health Organization -- ZIKV Zikavirus; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2018.02.002
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: The International Alliance for Biological Standardization organized the second workshop on human challenge trials (HCT) in Rockville, MD, in September 2017. The objective of this meeting was to examine the use of HCT, in response to the continuing human suffering caused by infectious diseases, preventable by the development of new and improved vaccines. For this, the approach of HCT could be valuable, as HCT can provide key safety, tolerability, immunogenicity, and efficacy data, and can be used to study host-pathogen biology. HCT can generate these data with speed, efficiency and minimal expense, albeit not with the same level of robustness as clinical trials. Incorporated wisely into a clinical development plan, HCT can support optimization or down-selection of new vaccine candidates, assuring that only the worthiest candidates progress to field testing. HCT may also provide pivotal efficacy data in support of licensure, particularly when field efficacy studies are not feasible. Many aspects of HCT were discussed by the participants, including new and existing models, standardization and ethics. A consensus was achieved that HCT, if ethically justified and performed with careful attention to safety and informed consent, should be pursued to promote and accelerate vaccine development. Highlights: HCT can provide key safety, tolerability, immunogenicity, and efficacy data. HCT can generate these data with speed, efficiency and minimal expense. However, HCT do not have the same level of robustness as clinical trials. HCT can support optimization or down-selection of new vaccine candidates. HCT may also provide pivotal efficacy data in support of licensure.